### STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS DEPARTMENT OF ENVIRONMENTAL MANAGEMENT OFFICE OF AIR RESOURCES 

### AIR POLLUTION CONTROL REGULATION NO. 26

CONTROL OF ORGANIC SOL VENT EMISSIONS FROM MANUFACTURERS OF SYNTHESIZED PHARMACEUTICAL PRODUCTS

Effective 19 Novemberl992 LastAmended 19 July 2007

AUTHORITY: These regulations are authorized pursuant to R.I. Gen. Laws§ 42-l7.l-2(s) and 23-23, as amended , and have been promulgated pursuant to the procedures set forth in the R.I. Administrative Procedures Act, R.I. Gen. Laws Chapter 42-35.RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT OFFICE OF AIR RESOURCES AIR POLLUTION CONTROL REGULATION NO
. 26 CONTROL OF ORGANIC SOL VENT EMISSIONS FROM MANUFACTURE OF SYNTHESIZED PHARMACEUTICAL PRODUCTS 

### TABLE OF CONTENTS
26
.l Definitions
.. .. ... ... .. .. .. ..... .. .. .. .. . .. .. .. ..... ..... ... .. . .... ..... ....... ...... ...... .. .... .......... .. ........... ............ ..... ....... ...... .... ... .. ... l
26.2 Applicability
........... . ....................... ......................................... .......................... .. ................................ ....... ..... 2
26.3 Standards
.. .. ................................................................................. .... ............................................... ..... ... .........2
26.4 Test Methods and Compliance Procedures
... . .. .. .. .. ... .. .. .. . ... . ... .. .. .. .. .... .. . .. .. . ... . ... .. .... .. .. ... ....... . ... . .. .. .. ....... .. ... ....4
26.5 Monitoring for Air Pollutio n Control Equipment.
..................... ....................................................... .. ...............6
26.6 Recordkeeping
....................... .. ............................................... . ........................................................................6
26.7 Reporting
... ...... ... .... ....... .. . .. ... .. ... ..... ... .. ... .. .. .. .. .. .. . ... . .. .. .. .... . ... . .... .. .. .. .. . .. ... .. .. .. ... .. ...... ... .. ..... .. ... . .. ... .. .. ..... .. .. .. . 7
26.8 General Provisions
.................. ... ........ . ... . ..... ....... ... .. .. ... ... .. ..... .. .... .. . ... . .. ....... ....... .. .. .. . ... . ... .... .. ...... ..... ...... ...... .9

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### RHODE ISLAND DEPARTMENT OF ENVIRONMENTAL MANAGEMENT OFFICE OF AIR RESOURCES AIR POLLUTION CONTROL REGULATION NO. 26 CONTROL OF ORGANIC SOLVENT EMISSIONS FROM MANUFACTURE OF SYNTHESIZED PHARMACEUTICAL PRODUCTS 

### 26.1 Definitions Unless otherwise expressly defined in this section, the terms used inthis regulation shall be defined by reference to the Rhode Island Air Pollution Control General Definitions Regulation. As used in this regulation, the following terms shall, where the context permits, be construed as follows: 26.1.1 

### "Condenser" means any device which cools a gas stream to a temperature which removes specific voe by condensation. 26.1.2 

### "Control System" means any number ofcontrol devices, including condensers, which are designed and operated to reduce the quantity ofVOe emitted to the atmosphere. 26.1.3 

### "Enclose" means to cover a volatile organic liquid surface in a manner such that it is not exposed to the atmosphere. 26.1.4 

### "Pharmaceutical Product and Intermediate" means any drug or chemical substance or any intermediate used to make a drug or chemical substance which is intended to be administered to a person or animal to prevent or cure disease or otherwise enhance physical ormental welfare. 26.1.5 

### "Production equipment exhaust system" means a device for collecting and directing out ofthe work area VOC fugitive emissions from reactor openings, centrifuge openings, and other vessel openings for the purpose ofprotecting workers from excessive voe exposure. . 26.1.6 

### "Reactor" means a vat or vessel, which may bejacketedto permit temperature control, designed to contain chemical reactions. 26. l.

### 7 "Separation operation" means a physical or chemical process that separates a mixture ofcompounds and solvents into two or more components. Specific mechanisms include but are not limited to: extraction, centrifugation, filtration, and crystallization
. 26.1.8 

### "Synthesized pharmaceutical manufacturing" means manufacture of pharmaceutical products and intermediates by chemical synthesis. The production and recovery ofmaterials produced via fermentation, extraction of Page I of 10organic chemicals from vegetative materials or animal tissues, and formulation and packaging ofthe product are not considered synthesized pharmaceutical manufacturing. ·
26.2 Applicability 26.2
. 1 This regulation applies to the following sources ofvolatile organic compounds (VOC) at all synthesized pharmaceutical manufacturing facilities: (a) Reactors; (b) Distillation operations; ( c) Crystallizers; ( d) Centrifuges; ( e) Vacuum dryers; (f) Air dryers; (g) Production equipment exhaust systems; (h) Rotary vacuum filters and other filters; (i) Storage tanks; G) In-process tanks; and (k) Leaks. 26.2.2 The owner or operator ofa synthesized ph armaceutical manufacturing facility subjectto this regulation shall control the 

## voe emissions from each vent which has the potential to emit 15 pounds per day [lb/day] (6.8 kilograms per day (kg/day)) ormore of

## voe from reactors, distillation operations, crystallizers, centrifuges, and vacuum dryers. 

## voe emissions shall be controlled in accordance with the requirements in Section 26.3. 26.2.3 Where e:vertheterm "Volatile Organic Compound" or "VOC" is used in Sections 26.2 through 26.7, t:ras term should be read as "Volatile Organic Compound and Halogenated Organic Compound" or "VOC aHd HOC". 26.2.4 An owner oroperator ofa facili ty which has sources whose emissions are below the threshold in Subsection 26.2.2 shall comply with the certification, recordkeeping, and reporting requirements in Sections 26.6 and 26.7 for those sources. 26.2.5 Any facility or source that becomes or is currently subjectto the provisions ofthis regulation by exceeding the applicability threshold in Subsection 26.2.2 will remain subject to this regulation even if the emissions later fall below the applicability threshold.
26.3 Standards Page 2 of lO

### By 19 November 1994 the following emissions limitations must be met. Any new source commencing operation after 19November1992 must meet the following emission limitations upon commencing operations : 26
.3.l Surface condensers or equivalent controls. (a) If

### surface condensers are used, the condenser outlet gas temperature shall not exceed the allowable temperature limit described for each associated vapor pressure in the following table; or
Allowable condenser outlet gas 

## voe vapor pressure at temperature, EC 20EC, kPa (psi) -25 >40.01 (5.8)

- 15 >20.0 (2
.9)

0 >10.0 (1.5) 10 >7.0 (1.0) 25 >3.5 (0.5)
(b) If

### other controls such as carbon absorption or incineration are used, the 

## voe emissions shall be reduced by at least as much as they would be by using a surface condenser. All such controls J;llUSt 

### be approved by the Department. 26.3.2 Air dryers and production equipment exhaust systems. The owner or operator ofa synthesized pharmaceutical manufacturing facility subject to this regulation shall reduce the 

## voe emissions from all air dryers and production equipment exhaust systems: (a) By at least 90 percent on an hourly basis ifactual emissions from all air dryers and production equipment exhaust are 150 kg/day (330 lb/day) or more of

## voe or (b) 

### To 15.0 kg/day (33 lb/day) or less ifactual emissions from all air dryers and production equipment exhaust are less than 150 kg/day (330 lb/day) ofVOC. 26.3.3 Storage Tanks. The owner or operator ofa synthesizedpharmaceutical manufacturing facility subject to this regulation shall reduce the 

## voe emissions from storage tanks by: Page 3of10

### (a) Providing a vapor balance system or equivalen t control that is at least 90 percent effective in reducing emissions from truck or railcar deliveries to storage tanks 

### with capacities greater than 7,500 liters (L) (2,000 gallons [gal]) that store VOC with vaporpressures greater than 28.0 kiloPascals (kPa) (4.1 pounds per square inch [psi]) at 20EC (68EF); and (b) 

### Installing pressure/vacuum conservation vents set at a minimum pressure of 0.2 k.Pa (0.03 pounds per square inch atmospheric [psia]) on all storage tanks that store VOC with vapor pressures greater than 10
.0 kPa (1.5 psi) at 20EC (68EF). 26.3.4 Centrifuges, rotary vacuum filters, and other filters. The owner or operator ofa synthesized phannaceutical facility subject to this regulation shall enclose all centrifuges, rotary vacuum filters, and other filters having an exposed liquid surface ifthe liquid contains 

## voe and exerts a total 

## voe vapor pressure of3.50 kPa (0.5 psi) or more at 20EC (68EF), as determined by ASTM D2879

-83
. 26
.3.5 In-process tanks. The owner or operator ofa synthesized phannaceutical facility subject to this regulation shall install covers on all in

-process tanks that contain 

## voe at any time. These covers shall be constructed ofa nonporous ornonabsorbent material and form a tight seal with the sides ofthe tank and have no gaps or holes. These covers shall remain closed at all 

### times except when production, sampling, maintenance, or inspection procedures require operator access. 26.3.6 Leaks. The owner or operator ofa synthesized phannaceutical manufacturing facility subject to this regulation shall visually inspect for liquid leaks once per week and use a portable 

## voe detector to inspect for vapor leaks once per month to inspect all equipment listed in Subsections 26.2.1 (a) through (k). 

### All leaks repairs shall be completed as soon as practicable but no later than 15 calendar days after the leak. is found.
26.4 Test Methods and Compliance Procedures 

### 26.4.1 If

### a source uses air pollution control equipment to comply with the requirements ofthis regulation, compliance shall be demonstrated in accordance with 40 CFR Part 60, Appendix A, Method 18, Method 25, or Method 25A or any other EPA approved method which has been approved by the Director. Page 4of10

### 26.4.2 Selection ofa method for testing compliance shall be based on consideration oftotal concentration and speciation ofthe organics present and on consideration of the potential presence ofinterfering gases. Only Method 25, which measures VOC as carbon, may be used for determining destruction efficiency ofincinerators or catalytic incinerators. 26.4.3 Except as indicated in Subsections (a) and (b), 

### a test shall consist ofthree separate runs, each lasting a minimum of60 minutes, unless the Director determines that process variables dictate shorter sampling times. (a) When the test is being done to determine the efficiency ofa fixed

-bed carbon adsorption system with a common exhaust stack for all ofthe individual adsorber vessels, the test shall consist ofthree separate runs, each coinciding with one or more complete sequences through the adsorption cycles ofall the individual adsorber vessels. (b) When the test is being done to determine the efficiency ofa fixed

-bed carbon adsorption system with individual exhaust stacks for each adsorber vessel, each adsorber vessel shall be tested individually. The test for each adsorber vessel shall consist ofthree separate runs. Each run shall coincide with one or more complete adsorption cycles. 26.4.4 Method 1 or IA of40 CFR Part 60, Appendix A, shall be used for velocity traverses. 26.4.5 Method 2, 2A, 2C, or 2D of40 CFR Part 60, Appendix A, shall be used to measure velocity and volumetric flow rates. 26.4.6 Method 3 or 3A of40 CFR Part 60, Appendix A, shall be used for 02 and C02 analysis. · 26.4
.7 Method 4 of40 CFR Part 60, Appendix A, shall be used to measure stack gas moisture. 26.4.8 Methods 2, 2A, 2C, 2D, 3, 3A and 4 of40 CFR Part 60, Appendix A, shall be performed, as applicable, at least twice during each test run. 26.4.9 Use ofmodifications ofany ofthe analytical methods specified in Subsections 26.4. l 

### through 26.4.8 ofthis section shall be approved or disapproved by the Director on a case-by-case basis
. An 

### owner or operator shall submit sufficient documentation for the Director to find that the analytical methods specified in Subsections 26.4.1 through 26.4.7 will yield inaccurate results and that the proposed modification is appropriate. Page 5of1026.5 Monitoring for Air Pollution Control Equipment. 26.5.1 At a minimum, continuous monitors measuring the following parameters shall be installed on air pollution control equipment used to control sources subject to this regulation by [the date two years after the effective date ofthis regulation]: (a) Destruction device combustion temperature; (b) Temperature rise across a catalytic incinerator bed; (c) VOC concentration at the outlet ofa carbon adsorption unit at breakthrough; (d) Outlet gas temperature ofa refrigerated condenser; and (e) Outlet gas temperature ofa non-refrigerated condenser coolant supply system. 26.5.2 Each monitor shall be: (a) Equipped with a recording device, (b) Calibrated quarterly, and (c) Operated at all times that the associated control equipment is operating.
26.6 Recordkeeping 26.6.1 The owner or operator ofa pharmaceutical manufacturing facility subject to this shall maintain the following records beginning [the date two years after the effective date ofthis regulation]: (a) Recording ofpc,l!ameters listed in Subsection 26.5. (b) A record ofthe solvent true vapor pressure as determined by ASTM D2879

- 86, for each VOC used in a source which is subject to this regulation. For a pure solvent, a record ofpublished data reporting the true vapor pressure of that solvent as determined using ASTM D2879

-86 is acceptable to fulfill this requirement. 26.6.2 For any leak subject to Subsection 26.3.6, which cannot be readily repaired within 24 hours after detection, the following shall berecorded: (a) The name ofthe leaking equipment; Page 6of10(b) The date and time the leak is detected; (c) The action taken to repair the leak; and (d) The date and time the leak is repaired
. 26.6.3 All records required in this Subsection shall be maintained at the facility for a minimum offive years.
26.7 Reporting 26.7.I Initial Compliance Certification Plan 26
.7.I.I The owner or operator ofany facility containing sources subject to this regulation shall submit to the Director an initial compliance certification plan by [the date one year afterthe effective date ofthis regulation]. The owner or operator ofany facility that becomes subject to this regulation after [the date one year after the effective date ofthis regulation] shall submit an initial compliance certification for that source immediately upon start-up of the operation. 26.7.1.2 The initial compliance certification shall include as a minimum the following information: (a) The name and location ofthe facility; (b) The name, address and telephone number oftheperson responsible for the facility; (c) An identification ofsubject sources atthe facility; (d) The information specified in Subsection 26.7.1.3 for each subject source; and (e) The time at which the facility's "day" begins ifa time other than midnight local time is used to define a "day". 26.7.1.3 The initial compliance certification shall also include, as a minimum, the following information for each subject source: (a) Identification ofthe applicable emission limitation, equipment specification, or work practice, as specified in Section 26.3; Page 7of10(b) The method by which compliance has been or will be achieved; (c) For each source subject to numerical emission limitations, the estimated actual and potential emissions without control, and the basis for the estimate; 26.7.2 Final Compliance Certification 26
.7.2.1 By 19 November 1994 or immediately upon startup for a facility which becomes subject to this regulation after 19 November 1994, the owner or operator ofany facility containing sources subject to this regulation shall certify to the Directorthat the facility is in compliance with the provisions of

### this regulation. 26. 7.2.2 The final compliance certification shall include, at a minimum, the following information: (a) The method by which compliance has been achieved for each subject source; (b) For each source subject to numerical emission limitations, the estimated actual and potential emissions without control, and the basis for the estimate; (c) Identification ofthe control system(s) in use for each subject source; (d) The design performance efficiency ofthe control system; (e) For each source subjectto numerical emission limitations, the estimated emissions after control; (f) Certification that each subject source atthe facility is in compliance withthe applicable emission limitation, equipment specification, or work practice; (g) An identification ofany changes from the initial compliance certificationplan. 26.7.3 Reports ofNoncompliance with Standards (a) The owner or operator ofany facility containing sources subject to this section shall, for each incidence ofnoncompliance with the standards in Section 26.3, within 30calendar days ofbecoming aware ofsuch occurrence, supply the Director with the following information: (i) The name and location ofthe facility; Page 8of10

### (ii) The subject source(s) that caused the noncompliance with the standard; (iii) The time and date offirst observation of the incident ofnoncompliance; (iv) The cause and expected duration of the incident ofnoncompliance; (v) For sources subject to numerical emission limitations, the estimated rateofemissions (expressed in the units ofthe applicable emission limitation) during the incident and the operating data and calculations used in estimating the emission rate. (vi) The proposed corrective actions and schedule to correct the conditions causing the incidence ofnoncompliance. 26.8 General Provisions 

### 26.8.1

26.8.2



### 26.8.3

26.8.4 Purpose The purpose ofthis regulation is to limit volatile organic compound emissions from the manufacture ofsynthesized pharmaceutical products Authority These regulations are authorized pursilant to RI. Gen. Laws § 

### 42

-l7.l-2(s) and 23-23, as amended, and have been promulgated pursuantto the procedures set forth 

### in the R.I. Administrative Procedures Act, R.I. Gen
. Laws Chapter 42-35 

### Application The terms and provisions ofthis regulation shall be liberally construed to permitthe Department to effectuate the purposes ofstate law, 

### goals and policies. Severability If

### any provision ofthis regulation or the application thereofto any person or circumstance, is held invalid by a court ofcompetentjurisdiction , the validity ofthe remainder ofthe regulation shall not be affected thereby. Page 9of10

### 26.8.5



### Notice Given on: Public Hearing held: Filing Date: Effective Date: Effective Date
The foregoing regulation, "Control ofOrganic Solvent Emissions from Manufacturers ofSynthesized Pharmaceutical Products", as amended, is hereby adopted and filed with the Secretary ofState this 12th day of February, 2015, in

### accordance with the provisions ofChapters 23

-23 , 42-35, 42-17.1, 42-17.6, ofthe General Laws ofRhode Island of 1956, as amended.

Janet Coit, Director Department ofEnvironmental Management



### February 21, 2007 March 23, 

### 2007 June 29, 2007 July 19, 2007

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